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CAPA a necessary evil or a useful tool for promoting Corporate Creativity?

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Credit: J. Jariwala, Compliance Officer, FDA CDRH (2013) This blog will explore the use of CAPA as a creative/innovation tool in a business setting. We are first going to look at the background of CAPA, what it is, how it developed, how it is traditionally used, how it can be utilised for innovation, and the benefits and the drawbacks of CAPA as an innovation tool. What is CAPA? Corrective and Preventive Action or CAPA is a well known quality control and risk analysis procedure that has its origins in the pharmaceutical and medical device industries that has now been widely adopted across a number of sectors due to its inclusion in the ISO 9000 series. The process is focussed on identifying, investigating, understanding, and the correction of non-conformities with the aim on ensuring that these do not reoccur. The definition of CAPA is varies depending on the application with the main differences being the FDA GMP (Good Manufacturing Practice) application and the more generally use...
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